Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00012 (NCT NCT03435224)

Last Updated: 2024-10-01

Results Overview

Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

1-5 hours

Results posted on

2024-10-01

Participant Flow

Of the 39 enrolled participants, 29 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.

Participant milestones

Participant milestones
Measure	INVSENSOR00012 All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
Overall Study STARTED	29
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00012 All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
Overall Study Unable to achieve a minimum desaturation level	4

Baseline Characteristics

Desaturation Validation of INVSENSOR00012

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00012 n=25 Participants All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
Age, Customized < 18 years	0 Participants n=5 Participants
Age, Customized 18-50 years	25 Participants n=5 Participants
Age, Customized > 50 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Outcome measures

Outcome measures
Measure	INVSENSOR00012 n=269 blood samples All subjects consented are enrolled into the test group and will receive the INVSENSOR00012.
Oxygen Saturation (SpO2) Accuracy of Sensor	1.99 % of oxygen saturated hemoglobin

Adverse Events

INVSENSOR00012

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chelsea Frank

Masimo

Phone: (949) 297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place